Analyte Measurement and Management Device and Associated Methods

Abstract

A method for measuring and managing an analyte (e.g., blood glucose) in a bodily fluid includes storing a therapeutic administration protocol in a memory module of an analyte measurement and management device and measuring the analyte in the bodily fluid sample using an analyte measurement module of the device. The method also includes calculating, with a processor module of the device, a recommended therapeutic agent dosage (for example, an insulin dosage) and a recommended administration time for user-activated delivery of the dosage by employing the therapeutic administration protocol. The method further includes displaying the recommended therapeutic agent dosage and administration time to a user on a visual display of the device, delivering a therapeutic agent dosage to the user via a user-activated therapeutic agent delivery device, and detecting the user-activated administration of the therapeutic agent using a delivery device communication module of the device. In addition, the method includes communicating the aforementioned detection to the processor module and/or memory module using the delivery device communication module. The method employs analyte measurement, memory, processor, and delivery device modules, as well as a visual display, and user interface that are integrated as a single hand-held unit.

1 . A method for measuring and managing an analyte in a bodily fluid, the method comprising:
 storing at least one therapeutic administration protocol in a memory module of an analyte measurement and management device;   measuring an analyte in a bodily fluid sample using an analyte measurement module of the analyte measurement and management device;   calculating at least a recommended therapeutic agent dosage and a recommended administration time for user-activated delivery of the recommended therapeutic agent dosage by employing the therapeutic administration protocol stored in the memory module in a processor module of the analyte measurement and management device;   displaying at least the recommended therapeutic agent dosage and recommended administration time to a user on a visual display of the analyte measurement and management device;   delivering a therapeutic agent dosage to the user via a user-activated therapeutic agent delivery device;   detecting the user-activated administration of the therapeutic agent using a delivery device communication module of the analyte measurement and management device; and   communicating such detection to at least one of the processor module and memory module using the delivery device communication module;   wherein the analyte measurement, memory, processor, visual display, user interface and delivery device communication module are integrated as a single hand-held unit.   
     
     
         2 . The method of  claim 1  further including the step of inputting meal information by a user via a user interface of the analyte measurement and management device. 
     
     
         3 . The method of  claim 1  wherein the analyte is blood glucose and the therapeutic agent is insulin. 
     
     
         4 . The method of  claim 1  wherein the displaying step displays the recommended therapeutic agent dosage in the format of user button pushes on the user-activated therapeutic agent delivery device. 
     
     
         5 . The method of  claim 1  wherein the delivery step is accomplished via the user pushing a button on the user-activated therapeutic agent delivery device. 
     
     
         6 . The method of  claim 1  wherein the communicating step is accomplished using RFID techniques. 
     
     
         7 . The method of  claim 1  wherein the delivering step includes delivering a therapeutic agent dosage of a therapeutic agent selected from the group consisting of medications for metabolic management, hormonal therapy agents, oncology agents, pain management agents, regenerative medicine agents, and a combination thereof. 
     
     
         8 . The method of  claim 1  further including the step of confirming delivery of the therapeutic agent and actual therapeutic agent dosage by the user via a user interface of the analyte measurement and management device. 
     
     
         9 . The method of  claim 1  wherein the therapeutic administration protocol of the calculating step uses therapeutic agent type, a most recent analyte measurement value, time of the most recent analyte measurement, at least one previous analyte measurement value, at least one previous therapeutic agent dosage, and time of the at least one previous therapeutic agent dosage during the calculation. 
     
     
         10 . The method of  claim 1  wherein further including the step of generating a reporting summary by the processor module, the reporting summary including at least a percentage of detected user-activated administration in comparison to recommended therapeutic agent dosages. 
     
     
         11 . The method of  claim 10  further including the step of displaying the reporting summary on the visual display. 
     
     
         12 . The method of  claim 10  further including outputting the reporting summary from the analyte measurement and management device to an external device. 
     
     
         13 . The method of  claim 1  wherein the detecting step employs a wireless technique. 
     
     
         14 . The method of  claim 1  further including the step of generating an alarm using an alarm module of the analyte measurement and management device when the medical delivery device communication module has not detected user-activated administration of the therapeutic agent within a predetermined time window around the recommended administration time. 
     
     
         15 . The method of  claim 1  further including the step of updating the therapeutic administration protocol stored in the memory module. 
     
     
         16 . The method of  claim 1  further including the step of:
 updating reporting summary software stored in the memory module.   
     
     
         17 . The method of  claim 1  further including the steps of:
 retrieving a recommended therapeutic agent dosage and a recommended administration time from the memory module; and   displaying the retrieved recommended therapeutic agent dosage and the retrieved recommended administration time to user on the visual display.   
     
     
         18 . The method of  claim 1  wherein the detecting step includes detecting an actual therapeutic agent dosage and actual therapeutic agent administration time. 
     
     
         19 . The method of  claim 18  further including the step of:
 storing a result of the measuring step, the recommended therapeutic agent dosage, the actual therapeutic agent dosage and the actual therapeutic agent administration time in the memory module.   
     
     
         20 . The method of  claim 1  further comprising the step of:
 selecting a therapeutic administration protocol for use in the calculating step from a plurality of therapeutic administration protocols stored in the memory module.